Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates - Tabular View

Tracking Information

First Received Date ^ICMJE

January 10, 2008

Last Updated Date

January 22, 2008

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants [ Time Frame: 100 days or discharge from hospital ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00599053 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection. [ Time Frame: 100 days or discharge from Hospital ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Official Title ^ICMJE

Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Brief Summary

Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for BPD. We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bacteria Infection
Respiratory Tract Infections

Intervention ^ICMJE

Drug: Azithromycin

Study Arms / Comparison Groups

Experimental: Early treatment with azithromycin
No Intervention: Expectant (usual) management

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Infants weighing <1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.

Exclusion Criteria:

Severe respiratory distress syndrome with survival unlikely >7 days, Congenital malformations

Gender

Both

Ages

up to 3 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Robert L Schelonka, MD

205-934-6450

rschelon@uab.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00599053

Responsible Party

Robert L. Schelonka, MD-Principal Investigator, University of Alabama at Birmingham

Study ID Numbers ^ICMJE

F061228003

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Robert L Schelonka, MD

University of Alabama at Birminham

Information Provided By

University of Alabama at Birmingham

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP